How to Check REMS Requirements Before Starting a Medication
Before you start a new medication, especially one for a serious condition, you need to ask: Does this drug have REMS requirements? Itâs not just a formality-itâs a safety checkpoint that could prevent life-threatening side effects. The FDA requires Risk Evaluation and Mitigation Strategies (REMS) for drugs with serious risks, like birth defects, severe infections, or sudden brain reactions. If you skip checking REMS, you might get stuck waiting days for a prescription, or worse, end up in the hospital because a simple step was missed.
What Exactly Is a REMS?
REMS stands for Risk Evaluation and Mitigation Strategies. Itâs not a suggestion. Itâs a legal requirement the FDA puts on certain medications to make sure the benefits outweigh the dangers. Think of it like a safety net. Some drugs are so powerful-or so risky-that the FDA wonât approve them unless doctors, pharmacists, and patients follow strict rules.
These programs started after the Food and Drug Administration Amendments Act of 2007. Since then, 76 REMS programs have been approved. Some are simple. Others? Theyâre complicated. For example, isotretinoin (Accutane) needs both the doctor and patient to register in the iPLEDGE system. Zyprexa Relprevv can only be given in a certified clinic where staff watch you for three hours after the shot. Why? Because some patients have sudden, dangerous reactions.
What Does a REMS Program Include?
Not all REMS are the same. Theyâre built around the specific danger of the drug. Hereâs what you might run into:
- Medication Guides: A printed handout you get every time you fill the prescription. It explains risks in plain language. But donât just take it and toss it-read it.
- Communication Plans: The drugmaker sends training materials to doctors and pharmacists. This isnât optional. They need to know what to watch for.
- Elements to Assure Safe Use (ETASU): This is where things get serious. ETASU can mean prescriber certification, mandatory lab tests, patient registries, or even requiring the drug to be given in a hospital.
- Implementation Systems: How the whole system tracks whoâs enrolled, whoâs certified, and whoâs been monitored.
Take mycophenolate, used after organ transplants. It can cause miscarriages. The REMS requires women of childbearing age to have a negative pregnancy test before each refill and to use two forms of birth control. If you skip this, youâre not just breaking a rule-youâre risking a babyâs life.
How to Check REMS Requirements Before Prescribing or Filling
You donât have to guess. There are clear, official steps to follow.
- Look at the prescribing information. Every drugâs official label (available on DailyMed or the manufacturerâs site) says right at the top if a REMS applies. If it does, it lists exactly whatâs required.
- Use the FDA REMS Public Dashboard. Go to fda.gov/drugs/rems. You can search by drug name, company, or condition. The dashboard shows if the REMS is active, what elements it has, and when it was last updated. Pro tip: The dashboard was upgraded in March 2023-itâs faster, clearer, and links directly to each REMS programâs website.
- Check the manufacturerâs REMS website. Many drugs have their own dedicated REMS pages. For isotretinoin, itâs ipleDGEprogram.com. For thalidomide, itâs Celgeneâs REMS site. These sites have enrollment forms, training videos, and FAQs.
- Call the pharmacy. Pharmacists are on the front lines. If youâre unsure, call the pharmacy where youâll pick up the prescription. They can tell you if the drug needs special paperwork or if the doctor needs to be certified. The Opioid Analgesic REMS FAQ even says: âContact the pharmacy that dispensed the medication.â
- Verify prescriber certification. If the REMS requires the doctor to be certified, make sure theyâve completed the training. For opioids, this means taking a CME course. For thalidomide, itâs a 65-minute online module with a test. Ask your doctor if theyâre certified-or help them find the training.
What Happens If You Ignore REMS?
Itâs not just about paperwork. People get hurt.
A 2022 survey by the National Organization for Rare Disorders found that 42% of patients on REMS drugs faced delays-on average, over six business days-because someone didnât complete a step. One patient waited three weeks to get her mycophenolate because her doctor didnât know he needed to register. Another couldnât get isotretinoin because her dermatologist hadnât updated his iPLEDGE account.
Pharmacists report similar issues. On Reddit, a hospital pharmacist said they cut isotretinoin processing time from 45 minutes to 15 minutes just by making a checklist. Without that checklist? Mistakes happen.
And the FDA is watching. In 2022, they issued 27 warning letters to drug companies for REMS violations-up from 19 the year before. That means fines, delays in approvals, and public scrutiny.
Whoâs Responsible for REMS Compliance?
Everyone plays a role.
- Doctors: Must be certified if required. Must complete training. Must document patient counseling.
- Pharmacists: Must verify certification, check registries, and give the Medication Guide. Theyâre the last line of defense.
- Patients: Must enroll in registries if required. Must follow monitoring rules. Must report side effects.
Itâs not fair to put all the burden on patients. But if youâre prescribed a REMS drug, youâre part of the safety team. If your doctor says, âJust sign here,â push back. Ask: âDo I need to register? Do you need to be certified?â
How Long Does REMS Verification Take?
It varies. For a simple Medication Guide? Five minutes. For a drug like thalidomide? Youâre looking at 65 minutes of training, plus filling out forms, plus waiting for certification to process. The American Society of Health-System Pharmacists recommends setting aside 8 to 12 minutes per new REMS prescription.
Some systems are getting better. Eight of the top ten pharmacy benefit managers now check REMS status automatically when a prescription is sent electronically. That means fewer phone calls and fewer delays.
Whatâs Changing in REMS?
REMS isnât stuck in 2010. The FDA is trying to fix the problems.
In 2022, they modified 14 REMS programs to cut red tape-without cutting safety. Theyâre requiring all new REMS to include smartphone-friendly tools. That means apps you can use to check your status, get reminders, or upload lab results.
By 2026, blockchain might be used to track certification across hospitals and pharmacies. That could cut down on duplicate paperwork and false claims.
And the trend? REMS programs are growing. About 15-20% of new drugs need them. For cancer drugs? That number jumps to 85-90%. As treatments get more powerful, safety checks get more detailed.
Final Checklist Before Starting a REMS Medication
Before you take the first pill, run through this:
- â Is the drug listed on the FDA REMS Public Dashboard?
- â Did your doctor complete required training or certification?
- â Do you need to register in a patient registry?
- â Have you received and read the Medication Guide?
- â Are lab tests or pregnancy checks required before each refill?
- â Does the pharmacy know whatâs needed? Did they confirm with the manufacturer?
If you answer no to any of these, stop. Donât fill the prescription. Donât take the drug. Call your doctor. Call the pharmacy. Get it sorted.
REMS isnât about bureaucracy. Itâs about keeping you safe. The system isnât perfect. But skipping it? Thatâs not bravery. Thatâs risk.
How do I know if my medication has a REMS program?
Check the prescribing information that comes with the drug-either in the package insert or on DailyMed.gov. Look for a section titled "REMS" or "Risk Evaluation and Mitigation Strategy." You can also search the FDAâs REMS Public Dashboard at fda.gov/drugs/rems using the drugâs brand or generic name. If itâs listed, REMS requirements apply.
Do I need to register for REMS if Iâm just taking the medication?
It depends on the drug. For medications like isotretinoin or thalidomide, yes-you must enroll in a patient registry. Youâll need to complete a form, agree to monitoring, and sometimes take a safety quiz. For others, like certain opioids, you only need to receive a Medication Guide and have your doctor certified. Always check the specific REMS requirements for your drug.
Can my pharmacist tell me if a REMS is needed?
Yes. Pharmacists are trained to check REMS status before dispensing. If a drug requires prescriber certification or patient enrollment, the pharmacy system will flag it. If youâre unsure, ask your pharmacist directly: âDoes this medication have a REMS program? Do I need to do anything before I take it?â
What if my doctor doesnât know about the REMS?
Many doctors donât remember every REMS requirement, especially with new drugs. If your doctor says they donât know, help them. Direct them to the FDA REMS Public Dashboard or the drug manufacturerâs REMS website. They can find training modules, certification forms, and contact info. Itâs their responsibility-but youâre the one whoâll be affected if itâs missed.
How often do I need to renew my REMS certification?
It varies. For opioid REMS, prescribers must complete training every two years. For thalidomide, certification lasts one year. Patient registries like iPLEDGE require monthly or quarterly check-ins. Always check the specific programâs rules. The FDA doesnât send reminders-you have to track it yourself or ask your provider.
Are REMS programs only for rare diseases?
No. While 63% of drugs for rare diseases have REMS, so do many common ones. Opioids, isotretinoin, mycophenolate, and even some antivirals and blood thinners have REMS. The risk level-not how common the disease-is what triggers REMS. Even if youâve taken the drug before, always check: REMS can be added or changed after approval.
Webster Bull
December 12, 2025 AT 23:47John Fred
December 13, 2025 AT 21:07Harriet Wollaston
December 14, 2025 AT 02:06Lauren Scrima
December 16, 2025 AT 00:17nina nakamura
December 16, 2025 AT 14:59Hamza Laassili
December 17, 2025 AT 03:06Rawlson King
December 18, 2025 AT 21:07Cole Newman
December 19, 2025 AT 13:57Casey Mellish
December 19, 2025 AT 20:44